At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world.
Organization Overview:
At Lilly, we serve an extraordinary purpose. We make a difference for people around the globe by discovering, developing and delivering medicines that help them live longer, healthier, more active lives. Not only do we deliver breakthrough medications, but you also can count on us to develop creative solutions to support communities through philanthropy and volunteerism.
The Site Quality Leader (SQL) for Logistics Operations serves as the site quality leader role for the organization. The SQL assures that the quality system is implemented effectively and that processes are in place to assure the quality of Lilly products throughout the distribution process.
Responsibilities:
Ensures the operations are in compliance with applicable Quality Standards and Quality Practices
Applies knowledge of quality principles and cGMPs toward the development of local procedures
Exhibits critical business decision-making bringing about successful results; assures all quality related decisions are made in alignment with cGMPs and Lilly quality expectations
Plays the leadership role in implementation of quality systems
Defines and monitors the quality plan to ensure proper priority, resources, and direction have been provided
Assures continual Quality improvement and regulatory compliance across all operations; leads the development of improved and streamlined quality systems
Coordinates and manages regulatory inspections, defines and maintains inspection readiness activities, and interacts with regulatory agencies during inspections regarding cGMP issues
Participates on the NALO Lead Team, Quality Lead Team and Distribution Review Board; works collaboratively with NALO Operations to ensure development of systems that will facilitate streamlined workflow
Networks with other areas to understand best practices and share knowledge, participates in tactical and strategic business planning, and ensures customer needs are met
Participates in Human Resource Development, Human Resource Planning, and Performance Management plans for direct reports; recruits new talent
Communicates to and strives for integration of support groups outside of the plant; serves as a conduit for Corporate communications
Networks with other sites regarding new systems development
Develops plan for capital purchases
NALO Device Management Representative dotted line reporting to PDS/IDM Management Representative in compliance with ISO13485:2016 section 5.5.2.
Responsible for ensuring data integrity and good documentation practices while performing job tasks
Basic Qualifications / Requirements:
BS or equivalent in a scientific field
Minimum of 5 years experience in Production, Quality Control, Quality Assurance, or Technical Services
Additional Preferences:
High-quality skills including:
Ability to prioritize and to make critical decisions
Written and oral communication
Interpersonal/people skills, mentoring/leadership
Computer applications
Problem solving
Self-motivation
Leads the way for ensuring a fair and equitable work environment
Clear understanding of all cGMPs policies, procedures, and guidelines
Additional Information
This is not a remote position and requires on site presence
Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (https://careers.lilly.com/us/en/workplace-accommodation) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.
Lilly is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.
Our employee resource groups (ERGs) offer strong support networks for their members and help our company develop talented individuals for future leadership roles. Our current groups include: Africa, Middle East, Central Asia Network, African American Network, Chinese Culture Network, Early Career Professionals, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinos at Lilly, PRIDE (LGBTQ + Allies), Veterans Leadership Network, Women’s Network, Working and Living with Disabilities. Learn more about all of our groups.
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